MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. PERIFIX CONTINUOUS EPIDURAL TRAYS; PERIFIX 20 GA. EPIDURAL CATHETER

Model Number CE18TKCD

Device Problems Component Missing (2306); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2014

Event Type  Injury  

Event Description

As reported by the user facility: reports upon pulling the epidural catheter from the patient, it was noted that the catheter tip was missing.The patient required surgery for removal of the catheter tip.During a follow-up phone call with the facility, the rn risk manager stated there were no complications with the insertion of the catheter.The patient was sitting upright during the first attempt to remove the catheter, and the doctor felt resistance.The patient was then repositioned into a curled positioned.The catheter was advanced a little and then it snapped out.This was when the catheter was observed to have the tip missing.The catheter did not look stretched.The patient recovered from the catheter removal surgery with no complications.The entire portion of the catheter fragment was successfully removed from the patient.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report # (b)(4).During a follow up call the facility, the reporter confirmed that they cannot release the sample; however, photos of the involved catheter were sent.Based on the returned photos of the involved catheter, the catheter appeared fractured approximately 10cm from the catheter tip.The area at the tear appeared stretched.However, no specific conclusions could be drawn from the photos.The event description did indicate that resistance was met during the first attempt to remove the catheter.While no specific conclusion can be drawn, incidents of this nature can occur when a catheter becomes lodged between rigid body structures and is stretched beyond its design capabilities.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature noted during in-process or final product inspection.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or catheter material number.There were no other reports of this nature against the reported lot number.All available information has been forwarded to the device manufacturer of the catheter.If a physical sample is received or if additional pertinent information becomes available, a follow-up report will be filed.

• Brand Name: PERIFIX CONTINUOUS EPIDURAL TRAYS
• Type of Device: PERIFIX 20 GA. EPIDURAL CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; allentown PA
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109-9341 ; 6102660500
• MDR Report Key: 4036249
• MDR Text Key: 16853559
• Report Number: 2523676-2014-00308
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K813186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: CE18TKCD
• Device Catalogue Number: 332211
• Device Lot Number: 0061372468
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention